Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus
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|ClinicalTrials.gov Identifier: NCT00033644|
Recruitment Status : Terminated
First Posted : January 27, 2003
Last Update Posted : April 11, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus sargramostim in treating patients who have advanced, persistent, or recurrent cancer of the uterus.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Biological: sargramostim Drug: cisplatin Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: mitomycin C||Phase 2|
- Determine the antitumor activity of dacarbazine, mitomycin, doxorubicin, and cisplatin plus sargramostim (GM-CSF) in patients with advanced, persistent, or recurrent leiomyosarcoma of the uterus.
- Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: Patients receive dacarbazine IV over 2 hours, followed by mitomycin IV over 2-5 minutes, doxorubicin IV over 2-5 minutes, and cisplatin IV over 2 hours on day 1. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) once every 12 hours on days -6 to -3 before the first chemotherapy course and then on days 2-15 and 23-26 of all chemotherapy courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease receive a maximum of 4 courses. Patients achieving complete or partial response receive a maximum of 6 courses.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 12-28 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Evaluation of DMAP Plus GM-CSF in the Treatment of Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus|
|Study Start Date :||March 2002|
|Actual Primary Completion Date :||October 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033644
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|Study Chair:||Harry J. Long, MD||Mayo Clinic|